Deficiency of Anterior Cruciate Ligament
Conditions
Brief summary
Purpose:Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell.
Detailed description
1. Purpose: Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell. 2. Subject: Anterior cruciate ligament (ACL) injury 30 patients * ACL reconstruction: 10 * ACL reconstruction + Human cord blood derived mesenchymal stem cells and hyaluronic acid (Cartistem (TM)): 10 * ACL reconstruction + hyaluronic acid: 10 3. Hypothesis: Human Cord blood derived mesenchymal stem cells can enhance healing between bone tunnel and graft in ACL reconstruction.
Interventions
BIOLOGICALhyaluronic acid
ACL reconstruction and injection of hyaluronic acid under arthroscopy.
PROCEDUREACL reconstruction only
ACL reconstruction only without any injection under arthroscopy
BIOLOGICALCartistem(TM)
ACL reconstruction and injection of Cartstem(TM), human cord blood derived mesenchymal stem cell under arthroscopy.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Age 20\ 50 2. Lachman test grade II,III or Pivot shift test grade I,II,III or ACL rupture in MRI 3. prothrombin time (PT) (INR) \<1.5, activated partial thromboplastin time (aPTT) \<1.5 x control 4. Creatinine ≤2.0 ㎎/㎗, protein uria(dipstick) ≤ trace 5. Bilirubin ≤2.0 ㎎/㎗, aspartate aminotransferase (AST) /Alanine Aminotransferase (ALT) ≤100 IU/L 6. No surgery and radiation therapy in recent 6 weeks 7. No pregnancy 8. No combine ligament instability ≥ grade II in physical examination (grade 0: none, grade I: 0\ 5mm, grade II: 5\ 10mm, grade III: \>10mm) 9. voluntary singed a consent form
Exclusion criteria
1. Degenerative osteoarthritis in knee 2. Revision or other surgery history (stem cell treatment) 3. Chronic inflammatory joint disease like rheumatoid arthritis 4. Infectious disease need to administration of parenteral antibiotics 5. Autoimmune disease 6. Myocardial infarction, congestive heart failure, other serious heart disease 7. Uncontrolled hypertension 8. Serious medical disease 9. Pregnancy and breast-feeding 10. psychiatric disorder and epilepsy 11. Alcohol overuse 12. Smoking overuse 13. Administration of immunosuppressive agents like Cyclosporin A or Azathioprine in recent 6 weeks prior screening test 14. Patient participating in other clinical trials in recent 4 weeks 15. Combined ligament instability ≥ grade II in physical test. 16. No allergy history to gentamicin antibiotics 17. Hypersensitivity patient to bovine protein, hyaluronic acid, and anesthetic agent 18. Inappropriate patient judged by researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone formation on interface between bone tunnel and graft | Changes at 12 week, 24 week, 48 week after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Telos stress X-ray | Changes at 12 week, 24 week, 48 week after surgery |
| KT-2000 | Changes at 12 week, 24 week, 48 week after surgery |
| Arthroscopic grading of graft | 48 week after surgery |
| Instability assessing with physical examination | Changes at 12 week, 24 week, 48 week after surgery |
| Tunnel enlargement after anterior cruciate ligament reconstruction | Changes at 12 week, 24 week, 48 week after surgery |
| clinical knee scoring | Changes at 12 week, 24 week, 48 week after surgery |
Countries
South Korea
Outcome results
None listed